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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011236
Receipt No. R000013167
Scientific Title Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -
Date of disclosure of the study information 2013/07/20
Last modified on 2016/01/20

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Basic information
Public title Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -
Acronym Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation
Scientific Title Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -
Scientific Title:Acronym Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prospectively evaluate efficacy of mesalazine suppository in Japanese ulcerative colitis patients with active rectal inflammation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to disappearance of rectal bleeding
Rate of disappearance of rectal bleeding
Rate of adverse events
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Upon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Ulcerative colitis patients with rectal inflammation who has rectal bleeding or in remission.

2. Patients with the first attack or those in remission on salazopyrine or mesalazine less than 4 grams daily.
Key exclusion criteria 1. Past history of adverse effect to mesalazine.
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Katsuyoshi Matsuoka
Organization Keio University School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku Tokyo
TEL 03-3353-122
Email matsuoka@z2.keio.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Katsuyoshi Matsuoka
Organization Keio University School of Medicine
Division name Gastroenterlogy and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku Tokyo
TEL 03-3353-1211
Homepage URL
Email matsuoka@z2.keio.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 20 Day
Last modified on
2016 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013167

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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